Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 4INTERVENTIONAL

Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis

Evaluating Urinary Microbiome Modulation :An RCT of Antibiotic vs Gynoflor Prophylaxis in Postmenopausal Women With Recurrent Cystitis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This open-label, parallel-group randomized controlled trial compares two prophylaxis strategies for recurrent urinary tract infection (rUTI) in postmenopausal women: (1) nightly oral nitrofurantoin 100 mg for 6 months versus (2) a vaginal tablet containing Lactobacillus with ultra-low-dose estriol (Gynoflor: nightly for 14 days, then twice weekly to month 6). Participants (≥40 years) are randomized 1:1 in computer-generated blocks and followed for 6 months. The primary endpoint is the proportion with rUTI recurrence within 6 months. Secondary endpoints include time to first recurrence, antibiotic resistance in breakthrough infections, change in lower urinary tract symptoms (Thai RUTISS), and urinary microbiome measures (Lactobacillus dominance and community diversity by qPCR and 16S rRNA). Key assessments occur at baseline and month 6 (urinalysis, culture, urinary microbiome sampling, and kidney function). Adherence and adverse events are captured via twice-weekly phone/Line contacts. Approximately 100 participants (50 per arm) will be enrolled as a feasibility-sized pilot.

Who May Be Eligible (Plain English)

Who May Qualify: - Female, postmenopausal, age ≥40 years - Clinical history of recurrent urinary tract infection (rUTI) as assessed by the investigator - Able and willing to take assigned prophylaxis for 6 months - Able to attend baseline and Month 6 study visits and provide urine samples - Able to provide written willing to sign a consent form - Willing and able to complete twice-weekly phone/LINE follow-ups Who Should NOT Join This Trial: - Current symptomatic UTI at enrollment (may be treated and reconsidered after resolution) - Known hypersensitivity or contraindication to nitrofurantoin or to the Lactobacillus/estriol vaginal tablet (Gynoflor) or their excipients; significant renal impairment or other label-based contraindications to nitrofurantoin per local practice - Planned urologic surgery or procedure expected during the 6-month study period - Recent bacterial vaginosis (e.g., within the past month) or active vulvovaginal skin disorders precluding vaginal product use - History of hormone-dependent malignancy (e.g., breast, uterine, or cervical cancer) or unexplained abnormal vaginal bleeding - Significant liver disease (e.g., active hepatitis) or other conditions judged by the investigator to make participation unsafe - Participation in another interventional trial that could interfere with outcomes - Withdrawal of consent or severe adverse event requiring discontinuation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Female, postmenopausal, age ≥40 years * Clinical history of recurrent urinary tract infection (rUTI) as assessed by the investigator * Able and willing to take assigned prophylaxis for 6 months * Able to attend baseline and Month 6 study visits and provide urine samples * Able to provide written informed consent * Willing and able to complete twice-weekly phone/LINE follow-ups Exclusion Criteria: * Current symptomatic UTI at enrollment (may be treated and reconsidered after resolution) * Known hypersensitivity or contraindication to nitrofurantoin or to the Lactobacillus/estriol vaginal tablet (Gynoflor) or their excipients; significant renal impairment or other label-based contraindications to nitrofurantoin per local practice * Planned urologic surgery or procedure expected during the 6-month study period * Recent bacterial vaginosis (e.g., within the past month) or active vulvovaginal skin disorders precluding vaginal product use * History of hormone-dependent malignancy (e.g., breast, uterine, or cervical cancer) or unexplained abnormal vaginal bleeding * Significant liver disease (e.g., active hepatitis) or other conditions judged by the investigator to make participation unsafe * Participation in another interventional trial that could interfere with outcomes * Withdrawal of consent or severe adverse event requiring discontinuation

Treatments Being Tested

DRUG

Nitrofurantoin

Nightly oral nitrofurantoin 100 mg for 6 months as prophylaxis for recurrent UTI in postmenopausal women. If symptomatic UTI occurs, treat per standard care and, once resolved, continue assigned prophylaxis to complete 6 months. Monitoring per protocol: baseline and month-6 visits with urinalysis, urine culture, urinary microbiome, and kidney function; twice-weekly phone/Line check-ins for adherence, symptoms, and adverse events.

DRUG

Gynoflor

Vaginal tablet containing Lactobacillus with ultra-low-dose estriol. Insert 1 tablet nightly for 14 days, then twice weekly through month 6 as prophylaxis against recurrent urinary tract infection. If a symptomatic UTI occurs, treat per standard of care; after resolution, continue assigned prophylaxis to complete 6 months. Monitoring identical to comparator.

Locations (1)

Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, Phayatai Ratchathewi, Thailand